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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 69586

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
April 24, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Baxter Healthcare Corp.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

Baxter Amia Automated PD systems are used in the treatment of adult renal failure patients to perform automated peritoneal dialysis.

Z-0932-2015
Recall number
Z-0932-2015
Initiated
April 24, 2014
Classification
Class II
Status
Terminated
Recalling firm
Baxter Healthcare Corp.
Quantity
55 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
System error 01779 is produced when the battery cannot be charged due to specific voltage differences between the battery and the charger.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

System error 01779 is produced when the battery cannot be charged due to specific voltage differences between the battery and the charger.

Code information

Product Code: 5C9310

Distribution pattern

Nationwide Distribution including GA, MA, NC, NY, PA, and WA.